Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults
Study Details
Study Description
Brief Summary
The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Experimental This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement |
Drug: Adriamycin
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone/Prednisolone
Drug: VP16
Drug: Ifosfamide
Drug: Methotrexate
Drug: G-CSF
Drug: Rituximab
Drug: Vincristine/Vindesine
Procedure: Irradiation (in specific conditions)
|
Outcome Measures
Primary Outcome Measures
- Remission rate []
- Remission duration []
- Disease free survival []
- Overall survival []
Secondary Outcome Measures
- Dose and time compliance []
- Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) []
- Death under therapy and in complete remission (CR) []
- Localisations of relapse []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
-
Age > 15 years
-
Written informed consent
Exclusion Criteria:
-
Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
-
HIV infection
-
Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
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Known severe allergy to foreign proteins
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Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
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Pregnancy or nursing
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Participation in other studies that interfere with study therapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hospital, Medical Dept. II | Frankfurt | Germany | 60590 |
Sponsors and Collaborators
- Nicola Goekbuget
Investigators
- Principal Investigator: Nicola Goekbuget, Dr. med., University Hospital of Frankfurt (Main)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GMALL05